Yashsvini Jaiswal

Operations Associate

Bengaluru, Karnataka, India6 yrs 3 mos experience

Highly Stable

Key Highlights

6.5+ years in Clinical Operations and Quality Assurance.
Expert in KPI development and regulatory compliance.
Transitioning to Clinical Business Analyst with MBA in Business Analytics.

Stackforce AI infers this person is a Clinical Operations and Quality Assurance professional in the Pharmaceutical industry.

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Skills

Core Skills

Kpi DevelopmentClinical OperationsData AnalysisQuality Assurance

Other Skills

Regulatory ComplianceStakeholder ManagementData VisualizationRoot Cause AnalysisCorrective and Preventive Action (CAPA)Deviation ManagementReporting & AnalysisAnalyticsExcel DashboardsPharmaceutical ManufacturingClinical AnalyticsU.S. Title 21 CFR Part 11 RegulationManufacturing Process ImprovementCross-functional InitiativesConstruction Site Inspections

About

I translate clinical and quality operations data into structured insights that drive better decisions. With 6.5+ years across LabCorp Drug Development, IPCA Laboratories, and Cipla, I have hands-on experience in KPI development, deviation tracking, CAPA management, inspection readiness, and cross-functional reporting — across both drug development and pharmaceutical manufacturing environments. I have supported GCP and GLP internal and sponsor audits, assisted in regulatory inspections by USFDA, WHO, EU, PMDA, and Health Canada, and built executive-level dashboards providing real-time visibility into study progress, risks, and prioritisation. I am currently completing an MBA in Business Analytics at Symbiosis International University and transitioning into a Clinical Business Analyst role — where I can apply my domain knowledge to improve reporting frameworks, streamline business processes, and enable data-driven decision-making at scale. Open to: Clinical Business Analyst · Business Analyst (Pharma/Life Sciences) · Clinical Data Analyst · Quality Analyst Core skills: KPI Development · Clinical Operations · QA & Audit Readiness · CAPA Management · Regulatory Compliance (USFDA/WHO/EU/PMDA) · Deviation Management · Excel VBA & Macros · Stakeholder Management #ClinicalResearch #ClinicalDataManagement #ClinicalOperations #CROIndustry #BusinessAnalyst #DataAnalytics #QualityAssurance #PharmaceuticalIndustry #CAPA #KPIReporting #OpenToWork

Experience

6 yrs 3 mos

Total Experience

2 yrs

Average Tenure

Current Experience

Labcorp

Data Associate

Sep 2022 – Nov 2025 · 3 yrs 2 mos · Bengaluru, Karnataka, India · Hybrid

Developed and tracked KPIs for study timelines, milestone adherence, deviation trends, and CAPA effectiveness across Clinical Operations and Quality functions.
Built and maintained executive-level dashboards and portfolio reports, providing leadership real-time visibility into study progress, risks, and prioritisation.
Supported GCP and GLP internal and sponsor audits, assisting in regulatory inspections by USFDA, WHO, EU, PMDA, and Health Canada.
Developed KPI-based audit readiness trackers, reducing inspection preparation time and improving compliance documentation quality.
Collaborated with cross-functional teams across Clinical, Quality, and Regulatory functions to align data requirements and improve reporting consistency.
Contributed to risk-based quality monitoring frameworks, enabling proactive identification and mitigation of compliance risks across R&D portfolios.
Identified high-impact process improvement opportunities across Clinical Operations and Quality, enhancing reporting efficiency and compliance visibility.

KPI DevelopmentClinical OperationsRegulatory ComplianceData AnalysisStakeholder Management

Ipca laboratories limited

2 roles

Junior Officer Quality Assurance

Aug 2017 – Dec 2019 · 2 yrs 4 mos

Quality AssuranceRoot Cause Analysis

Quality Assurance Officer

Aug 2017 – Dec 2019 · 2 yrs 4 mos

Managed end-to-end deviation investigations and CAPA lifecycle management, ensuring compliance with regulatory requirements and internal quality standards.
Developed and monitored quality KPIs including deviation trends, audit observations, and CAPA closure timelines.
Supported inspection readiness programmes by aligning quality data and documentation with regulatory expectations.
Prepared and reviewed Annual Product Quality Review (APQR) reports for completeness, accuracy, and regulatory compliance.
Conducted root cause analysis (RCA) for quality deviations and contributed to SOP revisions to improve operational efficiency.
Collaborated with manufacturing, QC, and QA teams to improve data accuracy and cross-functional reporting structures.

Corrective and Preventive Action (CAPA)Deviation ManagementQuality Assurance

Cipla

2 roles

Apprentice

Aug 2016 – May 2017 · 9 mos

Reviewed Batch Manufacturing Records (BMR) and ensured compliance with cGMP guidelines.
Supported APQR preparation and Out-of-Trend (OOT) analysis, providing structured data for quality reporting.
Assisted in root cause analysis and continuous improvement initiatives, contributing to reduction of batch-level quality deviations.
Assisted in data collection and graphical representation of in-process controls and finished product quality results.
Contributed to QA documentation, quality metrics reporting, and audit support activities.

Reporting & Analysis

Quality Assurance Specialist

Aug 2016 – May 2017 · 9 mos

Reviewed Batch Manufacturing Records (BMR) and ensured compliance with current Good Manufacturing Practice (cGMP) guidelines. Performed quality control and compliance monitoring activities within pharmaceutical manufacturing operations, supporting consistent product quality. Assisted in root cause analysis (RCA) and continuous improvement initiatives, contributing to reduction of batch-level quality deviations. Supported Annual Product Quality Review (APQR) preparation and Out-of-Trend (OOT) analysis, providing structured data for quality reporting. Contributed to QA documentation, quality metrics reporting, and audit support activities.